US 20050070930 A1
An implantable surgical mesh is provided, one embodiment of which includes a plurality of absorbable filaments, and a plurality of non-absorbable filaments. Substantially all of the plurality of non-absorbable filaments are substantially aligned in a single direction with substantially no cross-linking therebetween. The plurality of absorbable filaments are interwoven with the non-absorbable filaments to thereby form a bi-directional mesh structure prior to absorption of the absorbable filaments.
1. An implantable surgical mesh comprising:
a plurality of absorbable filaments;
a plurality of non-absorbable filaments;
wherein substantially all of the non-absorbable filaments are substantially aligned in a single direction with substantially no cross-linking therebetween; and
wherein the plurality of absorbable filaments are interwoven with the non-absorbable filaments to thereby form a bi-directional mesh structure prior to absorption of the absorbable filaments.
2. The implantable surgical mesh according to
3. The implantable surgical mesh according to
4. The implantable surgical mesh according to
5. The implantable surgical mesh according to
6. The implantable surgical mesh according to
7. The implantable surgical mesh according to
8. The implantable surgical mesh according to
9. The implantable surgical mesh according to
10. The implantable surgical mesh according to
11. The implantable surgical mesh according to
12. An implantable surgical mesh comprising:
a plurality of absorbable filaments;
a plurality of non-absorbable filaments;
wherein substantially all of the non-absorbable filaments are arranged in rows which are aligned in a single direction with substantially no cross-linking therebetween; and
wherein the plurality of absorbable filaments are arranged in rows which are aligned in a single direction and interwoven with the non-absorbable filaments to thereby form a bi-directional mesh structure prior to absorption of the absorbable filaments.
This application claims the benefit of U.S. Provisional Application Ser. No. 60/507,191 filed Sep. 30, 2003.
The present invention relates generally to implantable surgical meshes, and more particularly, to implantable surgical meshes that contain both absorbable and non-absorbable portions in a configuration such that, following absorption of the absorbable portions, the mesh becomes discontinuous in a predetermined direction.
2. Background Discussion
Implantable surgical meshes have been widely used for a variety of different surgical procedures such as hernia repair, pelvic floor repair, urethral slings for treating incontinence, and many others. A woven or knitted mesh structure is desirable in that it allows tissue ingrowth into and through the mesh. The tissue ingrowth is in the form of a tissue fibrosis, where non-oriented tissue cells invade the mesh and grow in a random, disorganized fashion. The combination of mesh and ingrown tissue, however, produces a relatively hard, inflexible construction that does not resemble the tissue structure that it is reinforcing or replacing. This is due, in part, to the fact that the mesh structure in combination with the random ingrowth pattern of the tissue does not reflect the natural, organized cell structure in the absence of the foreign body (mesh). Thus, the resulting relatively inflexible structure can lead to tissue erosion problems in proximity to the implant and/or to organs in the vicinity of the implant.
To alleviate these problems, it is known to reduce the amount of tissue ingrowth and decrease the rigidity of the implant by adding absorbable fibers to an otherwise non-absorbable mesh. One such mesh is Vypro®, which is manufactured by Ethicon, Inc. of Somerville, N.J. This mesh is comprised of a combination of about equal parts of polyglactin polymer filaments and polypropylene filaments. When the polyglactin absorbs, it significantly reduces the amount of mesh that remains within the body, leaving only the polypropylene behind.
Accordingly, there is a need for an improved implantable surgical mesh that reduces or alleviates the problems discussed above, and that promotes tissue ingrowth that more closely mirrors natural body tissue.
An implantable surgical mesh is provided, one embodiment of which includes a plurality of absorbable filaments and a plurality of non-absorbable filaments, wherein substantially all of the non-absorbable filaments are substantially aligned in a single direction with substantially no cross-linking therebetween, and wherein the plurality of absorbable filaments are interwoven with the non-absorbable filaments to thereby form a bi-directional mesh structure prior to absorption of the absorbable filaments.
In one embodiment, the plurality of absorbable and non-absorbable filaments are constructed in a woven configuration, and in another embodiment substantially all of the absorbable filaments are fill and substantially all of the non-absorbable filaments are wrap.
In an alternate embodiment, the plurality of absorbable and non-absorbable filaments are constructed in a knitted configuration. In further embodiments, the absorbable and non-absorbable filaments may alternate, the ratio of absorbable to non-absorbable filaments may be less or greater than 1:1.
The plurality of absorbable and non-absorbable filaments may alternatively be constructed in a combination knitted and woven configuration, or in a non-woven configuration.
In one embodiment, the non-absorbable filaments are selected from the group consisting of polypropylene, polyester, polyethylene, acrylic, polyamides, aramids, fluropolymer filaments, and flurocarbon filaments, and in yet another embodiment, the absorbable filaments are selected from the group consisting of polyglacting, polydioxanone, polycaprolactone, polylactic acid, and polylactide.
Also provided is an implantable surgical mesh having a plurality of absorbable filaments and a plurality of non-absorbable filaments, wherein substantially all of the non-absorbable filaments are arranged in rows which are aligned in a single direction with substantially no cross-linking therebetween, and wherein the plurality of absorbable filaments are arranged in rows which are aligned in a single direction and interwoven with the non-absorbable filaments to thereby form a bi-directional mesh structure prior to absorption of the absorbable filaments.
These and other features and advantages of the present invention will become apparent from the following more detailed description, when taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.
Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. Further, although the present invention is primarily described in conjunction with pelvic floor repair procedures, it is to be understood that the invention and the principles described herein can be incorporated into any implantable surgical mesh used for any purpose. Some of those uses include but are not limited to, incontinence repair, ligament or smooth muscle repair in orthopedic procedures, cartilage repair for plastic surgery, or tissue replacement in orthopedic joints such as the meniscus of the knee and the labrum of the shoulder. Additional uses are for rebuilding smooth muscle within the abdominal or thoracic cavities because of loss due to trauma or disease.
As was stated above, known implantable surgical meshes that incorporate absorbable and non-absorbable fibers leave behind (following absorption) a mesh structure that is continuous in both directions, thereby allowing randomized ingrowth substantially along the entire surface area of the mesh in a manner that does not approximate natural tissue growth. Referring now to
The present invention provides a mesh that will more closely resemble natural tissue structure, such as that of the pubocervical fascia. One embodiment of the present invention is illustrated in
Another method of weaving is a leno weave. In this construction two warp yarns are twisted and the fill yarns are passed through the twist,
It is also possible to create fabrics using other manufacturing techniques, which will eventually produce a product, after some of the yarns or filaments have absorbed, which is discontinuous and will provide support by connecting between two tissue areas, without significant connection between the yarns. These fabrics are constructed by knitting, which is a process of making cloth with a single yarn or set of yarns moving in only one direction. In weaving, two sets of yarns cross over and under each other. In knitting, the single yarn is looped through itself to make the chain of stitches. One method to do this is described as weft knitting, an example of which is shown in
A second method for knitting a fabric or mesh is warp knitting. In this method the yarns are introduced in the direction of the growth of the fabric (in the y direction) as is illustrated in
Different types of warp knits can be used to construct a fabric for this purpose, such as Tricots, Raschel and Cidega knits. In producing a warp knit with a Raschel knitting machine, multiple variations in construction can be achieved. Most will produce a fabric that will function essentially the same as described above. However, there is a technique in Raschel knitting that uses a “fall plate” that can produce a structure that will look more like a woven fabric, as shown in
A third method of constructing a fabric consists of combining weaving and knitting. This method is called Co-We-Nit and is illustrated in
In alternate embodiments according to the present invention, the plurality of absorbable and non-absorbable filaments are constructed in a non-woven configuration. For example,
Returning now to
In a preferred embodiment, the absorbable filament is polygalactin and the non-absorbable filament is Polypropylene monofilament of 2.0 mils to 7.0 mils diameter, however, any suitable biocompatible absorbable and non-absorbable filaments could be used. It may be desirable to select a non-absorbable filament to control the desired structure integrity time, i.e. the time in which is takes for the filaments to absorb. The following table illustrates the approximate length of time it takes for various absorbable fibers to completely absorb:
In addition to selecting different materials, the diameter of the filaments can be selected to alter the physical properties of the mesh. For example, the absorbable filaments may be of smaller, or larger diameters than the non-absorbable filaments. Increasing the diameter of the filament can increase the absorption time as well.
Although specific embodiments of the invention have been described herein, it is to be understood that any weave or knit patterns, or non-woven patterns, in which the absorbable filaments dissolve or are absorbed to leave behind a substantially uni-directional mesh structure is within the scope of the invention. Further, although the described embodiments show no interweaving among successive non-absorbable filaments, some cross-weaving can take place and still provide a mesh with substantially uni-directional filaments. For example, in
In yet another embodiment of the concept, the construction of the fabric can made from a non-woven process. In the non-woven process, filaments are mechanically deposited to form a mat. The mat is then treated to provide integrity. The treatment can include manipulation of the filaments to entangle them or melt them together, or bind them with an adhesive or curing resin. In this example, alternate strips of the mat can be composed of non-absorbable and absorbable material such that as the absorbable material absorbs and the mat structure becomes discrete strips of material. These remaining strips will be in grown with tissue and provide a unidirectional support for the tissue. As with the weaves or knits described above, yarns of non-absorbable material may be laid in in the non-woven fabric. If the deposited filaments are absorbable and are bound together either through mechanical, thermal or chemical methods, then as they dissolve, the non-absorbable yarns will remain and provide the structure for tissue in growth. As described above, these yarns can be interlaced as well as linear. Further, they can be in a sinusoidal pattern or other side to side type pattern, and can be in the machine (warp) direction, cross (weft or fill) direction or diagonal, so long as they provide permanent connection of the remaining structure to the surrounding tissue, and provide a support for the tissue as well as a scaffold for the tissue to grow on and in.
An additional method to create a structure which will have a continuous construction initially, and then a discontinuous structure after some of the material has dissolved is to build a lamination of different materials. In this example a sheet of absorbable material such as oxygenated regenerated cellulose (ORC) can be laminated to filaments of a non-absorbable material such as polypropylene. The sheet can be produced with a wet lay process such as in the manufacture of papers, or a dry lay process such as in the manufacture of felts or non-wovens, or as a film. Once the structure is placed in the body the ORC material will dissolve within a few days leaving the polypropylene in place. The polypropylene elicits a foreign body response and inflammation. The inflammation leads to fibrotic activity and the cascade of scarring occurs. Scar tissue forms around the polypropylene filaments covering them through their length but not producing a significant amount of cross over between them. This then produces an essentially discontinuous configuration of scar tissue.
Depending on the distance between the filaments, usually greater than 1000 microns, scar formation will not bridge across the gap. However some light tissue formation may occur. This may even be encouraged by crossing a very few filaments, either in the opposite direction, or by allowing some filaments to curve or wind enough to reach others. In this way building a support mechanism for injured or diseased tissue can be precisely controlled to match the original tissue in thickness and flexibility properties.
Although several embodiments of a mesh for pelvic floor prolapse repair have been described, those skilled in the art will recognize that various other mesh configurations can also be used in conjunction with the procedures and techniques described herein. It will be further apparent from the foregoing that other modifications of the inventions described herein can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.